As 2023 comes to a close, let’s take a look back at this year’s top patent decisions. Patent litigation had an active year with many important cases in contention for the top spots. These five decisions changed the legal landscape. From life sciences to industrial designs to trade shows, these decisions spanned a wide variety of patent law issues and signal that Constitutional patent rights are still exploring new legal questions and breaking new ground almost 250 years after our nation’s founding.
‘Amgen v. Sanofi,’ 598 U.S. 594 (2023)
The one and only patent case from the 2022-2023 term, the U.S. Supreme Court’s Amgen decision on patent enablement was widely watched across the biotechnology, chemical and pharmaceutical industries.
Amgen’s patents claimed a class of antibodies that bind to PCSK9, a protein involved in controlling blood levels of “bad” LDL cholesterol. Patent “enablement” requires that the patent describe the invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the invention.” 35 U.S.C. § 112(a).
The court found that Amgen’s specification disclosed only a small fraction of antibody amino acid sequences that could perform the claimed functions. 598 U.S. at 613. It held that this disclosure was not enabling and constituted “little more than two research assignments” that would force a scientist “to engage in ‘painstaking experimentation’ to see what work[ed].” The court stated that although there is no elevated enablement requirement for genus claims, “the more a party claims for itself the more it must enable.”
‘Columbia Sportswear v. Seirus Innovative Accessories,’ 80 F.4th 1363 (Fed. Cir. 2023)
The Federal Circuit’s Columbia decision is one of the most important design patent decisions since its 2008 en banc decision in Egyptian Goddess v. Swisa, 543 F.3d 665 (Fed. Cir. 2008), and may provide important context for assessing the court’s pending design patent appeal currently on rehearing en banc in LKQ v. GM Global, 71 F.4th 1383 (Fed. Cir. 2023).
Unlike a utility patent, a design patent protects an article of manufacture’s ornamental design rather than that article’s function.
Design patent infringement is analyzed under the ordinary-observer test. In assessing infringement, “comparison” prior art may be considered to provide context and “help highlight distinctions between the claimed and accused designs.” Columbia, 80 F.4th at 1377.
In Columbia, the Federal Circuit held that a design patent is limited to the article of manufacture identified in the claim. It reasoned that because design patent infringement and invalidity based on anticipation require “appli[cation] to the article of manufacture identified in the claim … this requirement also applies to comparison prior art.”
Columbia also addressed a second important question: the role of logos in assessing design patent infringement. Unlike trademark infringement, the “likelihood of confusion as to the source of the goods is not a necessary or appropriate factor” for consideration in design patent infringement. The Federal Circuit held that the accused product’s inclusion of a logo in the design had “the potential to render an accused design dissimilar to the patented one [and] should not be discounted.”
The Federal Circuit remanded to the lower court for further consideration under these standards.
‘Minerva Surgical v. Hologic’ 59 F.4th 1371 (Fed. Cir. 2023)
In Minerva, the Federal Circuit determined that a trade show demonstration prevented Minerva from patenting a surgical device. Back at the Federal Circuit after a 2021 decision from the Supreme Court on a separate issue, Minerva clarified whether a demonstration of a surgical device absent a use was sufficient to trigger the “public use” bar. This case provides yet another reminder for companies to file patent applications before setting up their trade show booth.
Under pre-2012 patent law, the “public use” bar precludes patenting if “the invention was … in public use … in this country, more than one year prior to the date of the application for patent in the United States.” 35 U.S.C. § 102(b) (pre-AIA). “Public use” occurs when “the invention was shown to individuals other than the inventor under no limitation, restriction, or obligation of confidentiality.” 59 F.4th at 1378.
Minerva held that demonstrating fifteen fully functional devices at a popular medical convention constituted “public use” because Minerva allowed sophisticated investors and physicians, without any confidentiality obligations, to evaluate and understand the technology that Minerva later sought to patent. The court distinguished prior decisions suggesting that public use required an actual use, not just a demonstration.
‘Ironburg Inventions v. Valve,’ 64 F.4th 1274 (Fed. Cir. 2023)
In 2012, Congress enacted patent reform legislation creating inter partes review (IPR) proceedings, allowing litigation at the Patent Office over patent validity. IPRs were designed to be a cheaper and faster alternative to district court litigation, and now the Patent Office has the busiest patent court in the nation. Ironburg answered a question of first impression on the scope of patent validity challenges raised in federal district court cases after an IPR.
IPRs at the Patent Office can trigger statutory IPR estoppel under 35 U.S.C. § 315(e)(2) and bar the challenger from raising invalidity challenges in a parallel district court litigation that “the petitioner raised or reasonably could have raised during that inter partes review.” 35 U.S.C. § 315(e)(2). In 2022, the Federal Circuit held that IPR “estoppel applies not just to claims and grounds asserted in the petition … but to all grounds not stated in the petition but which reasonably could have been asserted against the claims included in the petition.” California Institute of Technology v. Broadcom, 25 F.4th 976, 991 (Fed. Cir. 2022).
Ironburg answered an open question following Caltech, holding that a patent challenger could have reasonably raised grounds in its petition if they were “invalidity grounds a skilled searcher conducting a diligent search reasonably could have been expected to discover.” 64 F.4th at 1298.
‘Allgenesis Biotherapeutics v. Cloudbreak Therapeutics,’ 85 F.4th 1377 (Fed. Cir. 2023)
In Allgenesis, the Federal Circuit dismissed an IPR appeal for lack of Article III standing. This decision is important given that Congress is currently considering adding a standing requirement for IPRs in the 2023 PREVAIL Act legislation.
To show Article III standing, an appellant must prove it suffered an injury in fact. Allgenesis held no injury in fact based on appellant’s assertion of “potential infringement liability stemming from its development of” a pharmaceutical purportedly covered by Cloudbreak’s patent. 85 F.4th at 1381. The court discounted evidence of appellant’s 3-year-old Phase II clinical trials because appellant did not identify “concrete plans to develop and bring to market” the pharmaceutical such as “plans to conduct Phase III trials or seek FDA approval.” It also rejected an alleged injury based on collateral estoppel because appellant could challenge the issue in a separate appeal.
Monica Arnold is a senior associate, and Michelle Armond is a partner, at Armond Wilson LLP.
